Oklahoma 2024 Regular Session

Oklahoma Senate Bill SB1541 Compare Versions

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29-SENATE FLOOR VERSION
30-February 15, 2024
53+STATE OF OKLAHOMA
3154
55+2nd Session of the 59th Legislature (2024)
3256
33-SENATE BILL NO. 1541 By: Garvin
57+SENATE BILL 1541 By: Garvin
3458
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62+
63+AS INTRODUCED
3864
3965 An Act relating to the practice of pharmacy; allowing
4066 pharmacist to test or screen for and initiate drug
4167 therapy for minor, nonchronic h ealth conditions;
4268 specifying allowed tests; allowing pharmacist to
4369 dispense certain products under certain protocol;
4470 directing promulgation of rules; amending 59 O.S.
4571 2021, Section 353.1, as amended by Sect ion 6, Chapter
4672 288, O.S.L. 2022 (59 O.S. Supp. 202 3, Section 353.1),
4773 which relates to definitions used in the Oklahoma
4874 Pharmacy Act; modifying and adding definitions;
4975 updating statutory language and references; providing
5076 for codification; providing an effective date; and
5177 declaring an emergency .
5278
5379
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5783 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
5884 SECTION 1. NEW LAW A new section of law to be codified
5985 in the Oklahoma Statutes as Section 353.31 of Title 59, unless there
6086 is created a duplication i n numbering, reads as fol lows:
6187 A. A pharmacist may test or screen for a nd initiate drug
6288 therapy for minor, nonchronic health conditions as defined in
6389 Section 353.1 of Title 59 of the Oklahoma Stat utes.
64-B. To test for minor, nonchronic he alth conditions under this
65-section, the pharmacist may use any test that may guide clinical
66-decision-making and that is:
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141+B. To test for minor, nonchronic he alth conditions under this
142+section, the pharmacist may use any test that may guide clinical
143+decision-making and that is:
94144 1. Approved by, cleared by, or authorized under an emergency
95145 use authorization by the United States Food and Drug Administration;
96146 and
97147 2. Waived under the federal C linical Laboratory Improvement
98148 Amendments of 1988 (CLIA) or deemed to be CLIA-waived for use in
99149 patient care settings operating under a CLIA certificate.
100150 C. A pharmacist may dispense self-administered hormonal
101151 contraceptives under the protocol es tablished pursuant to subsection
102152 D of this section, regardless of whether the patient has obtained a
103153 prescription.
104154 D. The State Board of Pharmacy shall adopt rules establishing a
105155 protocol for dispensing self-administered hormonal contraceptives by
106156 January 1, 2025.
107157 SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.1, as
108158 amended by Section 6, Chapter 288, O.S.L. 2022 (5 9 O.S. Supp. 2023,
109159 Section 353.1), is amended to read as follows:
110160 Section 353.1. For the purposes of the Oklahoma Pharmacy Act:
111161 1. “Accredited program” means those seminars, classes,
112162 meetings, work projects, and oth er educational courses approved by
113163 the Board State Board of Pharmacy for purposes of continuing
114164 professional education;
115-2. “Act” means the Oklahoma Pharmacy Act;
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216+2. “Act” means the Oklahoma Pharmacy Act;
143217 3. “Administer” means the direct application of a drug, whether
144218 by injection, inhalation, in gestion, or any other means, to the body
145219 of a patient;
146220 4. “Assistant pharmacist” means any person presently licensed
147221 as an assistant pharmacist in the State of Oklahom a this state by
148222 the Board pursuant to Section 353.10 of this title and for the
149223 purposes of the Okla homa Pharmacy Act shal l be considered the same
150224 as a pharmacist, except where otherwise specified;
151225 5. “Board” or “State Board” means the State Board of Pharmacy;
152226 6. “Certify” or “certification of a prescription ” means the
153227 review of a filled pre scription by a licensed pharmac ist or a
154228 licensed practitioner with dispensing authority to confirm that the
155229 medication, labeling, and packaging of the filled prescription are
156230 accurate and meet all requirements prescribed by state and federal
157231 law. For the purposes of this paragraph, “licensed practitioner”
158232 shall not include optometrists with dispensing authority;
159233 7. “Chemical” means any medicinal substance, whether simple or
160234 compound or obtained through the process of the science and art of
161235 chemistry, whether of organic or inorganic origin;
162236 8. “Compounding” means the combining, admixing, mixing,
163237 diluting, pooling, reconstituting, or otherwise altering of a drug
164238 or bulk drug substance to create a drug. Compounding includes the
165-preparation of drugs or devices in anticip ation of prescription drug
166-orders based on routine, regularly observed prescribing patterns;
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290+preparation of drugs or devices in anticip ation of prescription drug
291+orders based on routine, regularly observed prescribing patterns;
194292 9. “Continuing professional education” means professional,
195293 pharmaceutical education in the general areas of the socioeconomic
196294 and legal aspects of he alth care; the properties and actions of
197295 drugs and dosage forms; and the etiology, characteristics, and
198296 therapeutics of the diseased state;
199297 10. “Dangerous drug”, “legend drug”, “prescription drug”, or
200298 “Rx Only” means a drug:
201299 a. for human use subject to 21 U.S.C. 353(b)( 1), or
202300 b. is labeled “Prescription Only”, or labeled with the
203301 following statement: “Caution: Federal law restricts
204302 this drug except for to use by or on the order of a
205303 licensed veterinarian.”;
206304 11. “Director” means the Executive Director of the State Board
207305 of Pharmacy unless context clearly indi cates otherwise;
208306 12. “Dispense” or “dispensing” means the interpretation,
209307 evaluation, and implementation of a prescription drug order
210308 including the preparation and delivery of a drug or device to a
211309 patient or a patient’s agent in a suitable container appr opriately
212310 labeled for subsequent administration to, or use by, a patient.
213311 Dispense includes sell, distribute, leave with, give away, dispose
214312 of, deliver, or supply;
215-13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
216-group of chain pharmacies un der common ownership and control that do
217-not act as a wholesale distributor, or any other person authorized
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364+13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
365+group of chain pharmacies un der common ownership and control that do
366+not act as a wholesale distributor, or any other person authorized
245367 by law to dispense or administer prescription drugs, and the
246368 affiliated warehouses or distributions of such entities under common
247369 ownership and control that do not act as a wholesale distributor.
248370 For the purposes of this paragraph, “dispenser” dispenser does not
249371 mean a person who dispenses only products to be used in animals in
250372 accordance with 21 U.S.C. 360b(a)(5);
251373 14. “Distribute” or “distribution” means the sale, purchase,
252374 trade, delivery, handling, storage, or receipt of a product, and
253375 does not include the dispensing of a product pursuant to a
254376 prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
255377 dispensing of a product approved under 21 U.S.C. 360b(b); provided,
256378 taking actual physical possession of a product or title shall not be
257379 required;
258380 15. “Doctor of Pharmacy” means a person licensed by the Board
259381 to engage in the practice of pharmacy. The terms “pharmacist”,
260382 “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall
261383 have the same meaning wherever they appear in the Oklahoma Statutes
262384 and the rules promulgated by the Board;
263385 16. “Drug outlet” means all manufacturers, repackagers,
264386 outsourcing faciliti es, wholesale distributors, third-party
265387 logistics providers, pharm acies, and all other facilities which are
266-engaged in dispensing, delivery, distribution, or storage of
267-dangerous drugs;
268388
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439+engaged in dispensing, delivery, distribution, or storage of
440+dangerous drugs;
295441 17. “Drugs” means all medicinal s ubstances and preparations
296442 recognized by the United States Pharmacopoeia Pharmacopeia and
297443 National Formulary, or any revision thereof, and all substances and
298444 preparations intended for external and/or internal use in the cure,
299445 diagnosis, mitigation, treatment , or prevention of disease in humans
300446 or animals and all substances and preparations, other than food,
301447 intended to affect the structure or any function of the body of a
302448 human or animals;
303449 18. “Drug sample” means a unit of a prescription drug packaged
304450 under the authority and responsibility of th e manufacturer that is
305451 not intended to be sold and is intended to promote the sale of the
306452 drug;
307453 19. “Durable medical equipment” has the same meaning as
308454 provided by Section 2 of this act 375.2 of this title;
309455 20. “Filled prescription” means a packaged pres cription
310456 medication to which a label has been affixed which con tains such
311457 information as is required by the Oklahoma Pharmacy Act;
312458 21. “Hospital” means any institution licensed as a hospital by
313459 this state for the ca re and treatment of patients, or a pharm acy
314460 operated by the Oklahoma Department of Veterans Affairs;
315461 22. “Licensed practitioner” means an allopathic physician,
316462 osteopathic physician, podiatric physician, dentist, veterinarian,
317-or optometrist licensed to practice and authori zed to prescribe
318-dangerous drugs within the scope of practice of such practitioner;
319463
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514+or optometrist licensed to practice and authori zed to prescribe
515+dangerous drugs within the scope of practice of such practitioner;
346516 23. “Manufacturer” or “virtual manufacturer” means with respect
347517 to a product:
348518 a. a person that holds an application approved under 21
349519 U.S.C. 355 or a license issued under 42 U.S.C. 262 for
350520 such product, or if such product is not the subject of
351521 an approved application or license, the person who
352522 manufactured the product,
353523 b. a co-licensed partner of the person described in
354524 subparagraph a of this paragraph that obtains the
355525 product directly from a person described in this
356526 subparagraph or subparagraph a of this paragraph,
357527 c. an affiliate of a person described in subparagraph a
358528 or b of this paragraph who receives the product
359529 directly from a person described in this subparagraph
360530 or in subparagraph a or b of this paragraph, or
361531 d. a person who contracts with another to manufacture a
362532 product;
363533 24. “Manufacturing” means the production, preparation,
364534 propagation, compounding, conversion, or processing of a device or a
365535 drug, either directly or indirectly by extraction from substances of
366536 natural origin or independently by means of chemical or biological
367537 synthesis and includes any pac kaging or repackaging of the
368-substances or labeling or relabeling of its container, and the
369-promotion and marketing of such drugs or devices. The term
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589+substances or labeling or relabeling of its container, and the
590+promotion and marketing of such drugs or devices. The term
397591 “manufacturing” manufacturing also includes the preparation and
398592 promotion of commercially avail able products from bul k compounds for
399593 resale by licensed pharmacies, licensed practitioners, or other
400594 persons;
401595 25. “Medical gas” means those gases including those in liquid
402596 state upon which the manufacturer or distributor has placed one of
403597 several cautions, such as “Rx Only”, in compliance with federal l aw;
404598 26. “Medical gas order” means an order for medical gas issued
405599 by a licensed prescriber;
406600 27. “Medical gas distributor” means a person licensed to
407601 distribute, transfer, wholesale, deliver, or sell medical gases on
408602 drug orders to suppliers or oth er entities licensed to use,
409603 administer, or distribute medical gas and may also include a patient
410604 or ultimate user;
411605 28. “Medical gas supplier” means a person who disp enses medical
412606 gases on drug orders only to a pati ent or ultimate user;
413607 29. “Medicine” means any drug or combination of drugs which has
414608 the property of curing, preventing, treating, diagnosing, or
415609 mitigating diseases, or which is used for that purpose;
416610 30. “Minor, nonchronic health condition” means a typically
417611 short-term health condition that is generally m anaged with
418-noncontrolled drug therapies, min imal treatment, or sel f-care, and
419-is limited to the following:
420-a. influenzas,
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663+noncontrolled drug therapies, min imal treatment, or sel f-care, and
664+is limited to the following:
665+a. influenzas,
448666 b. streptococcus,
449667 c. SARS-CoV-2,
450668 d. lice, and
451669 e. other emerging and existing pub lic health threats
452670 identified by the State Department of Health if
453671 permitted by an order, rule, or regulation;
454672 31. “Nonprescription drugs” means medicines or drug s which are
455673 sold without a prescription and which are prepackaged for use by the
456674 consumer and labeled in accordance with the requirements of the
457675 statutes and regulations of this state and the federal gov ernment.
458676 Such items shall also include medical and d ental supplies and
459677 bottled or nonbulk chemicals which are sold or offered for sale to
460678 the general public if such articles or preparations meet the
461679 requirements of the Federal Food, Drug, and Cosmetic Act, 21
462680 U.S.C.A., Section 321 et seq.;
463681 31. 32. “Outsourcing facility” including “virtual outsourcing
464682 facility” means a facility at one geographic location or address
465683 that:
466684 a. is engaged in the compounding of sterile drugs,
467685 b. has elected to register as an outsourcing facility,
468686 and
469-c. complies with all requirem ents of 21 U.S.C. 353b;
470-32. 33. “Package” means the smallest individual saleable unit
471-of product for distribution by a manufacturer or repackager that is
472687
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738+c. complies with all requirem ents of 21 U.S.C. 353b;
739+32. 33. “Package” means the smallest individual saleable unit
740+of product for distribution by a manufacturer or repackager that is
499741 intended by the manufacturer for ultimate sale to the dispenser of
500742 such product. For the purposes of this paragraph, “individual
501743 saleable unit” means the smallest container of a product introduced
502744 into commerce by the manufacturer or repackager that is intended by
503745 the manufacturer or repackager for individual sale to a dispenser;
504746 33. 34. “Person” means an individual, partnership, limited
505747 liability company, corporation, or association, unless the context
506748 otherwise requires;
507749 34. 35. “Pharmacist-in-charge” or “PIC” means the pharmacist
508750 licensed in this state responsible for the management control of a
509751 pharmacy and all other aspects of the practice of pharmacy in a
510752 licensed pharmacy as defined by Section 353.18 of this title;
511753 35. 36. “Pharmacy” means a place regularly licensed by the
512754 State Board of Pharmacy in which prescriptions, drugs, medicines,
513755 chemicals, and poisons are compounded or dispensed or such place
514756 where pharmacists practice the profession of pharmacy, or a pharmacy
515757 operated by the Oklahoma Department of Veterans Affairs;
516758 36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or
517759 “tech” means a person issued a Technician technician permit by the
518760 State Board of Pharmacy to assist the pharmacist and perform
519761 nonjudgmental, technical, manipulative, non-discretionary functions
520-in the prescription department under the immediate and direct
521-supervision of a pharmacist;
522762
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813+in the prescription department under the immediate and direct
814+supervision of a pharmacist;
549815 37. 38. “Poison” means any substance which when introduced into
550816 the body, either directly or by absorption, produces violent,
551817 morbid, or fatal changes, or which destroys living tissue with which
552818 such substance comes into contact;
553819 38. 39. “Practice of pharmacy” means:
554820 a. the interpretation and evaluation of prescription
555821 orders,
556822 b. the compounding, dispensing, administering, and
557823 labeling of drugs and devices, except labeling by a
558824 manufacturer, repackager, or distributor of
559825 nonprescription drugs a nd commercially packaged legend
560826 drugs and devices,
561827 c. the participation in drug selection and drug
562828 utilization reviews,
563829 d. the proper and safe storage of drugs and devices and
564830 the maintenance of proper records thereof,
565831 e. the responsibility for advising by counseling and
566832 providing information, where professionally necessary
567833 or where regulated, of therapeutic values, content,
568834 hazards, and use of drugs and devices,
569-f. the offering or performing of those acts, services,
570-operations, or transactions necessary in t he conduct,
571-operation, management, and control of a pharmacy, or
572835
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886+f. the offering or performing of those acts, services,
887+operations, or transactions necessary in t he conduct,
888+operation, management, and control of a pharmacy, or
599889 g. the ordering, performing, and interpreting of tests
600890 for minor, nonchronic health conditio ns that meet the
601891 requirements of Section 1 of this act and the
602892 initiation of drug therapy for minor, nonchronic
603893 health conditions,
604894 h. the dispensing of se lf-administered hormonal
605895 contraceptives as provided by Section 1 of this act,
606896 or
607897 i. the provision of those acts or services that are
608898 necessary to provide pharmaceutical care;
609899 39. 40. “Preparation” means an article which may or may not
610900 contain sterile produc ts compounded in a licensed pharmacy pursuant
611901 to the order of a licensed prescriber;
612902 40. 41. “Prescriber” means a person licensed in this state who
613903 is authorized to prescribe dangerous drugs within the scope of
614904 practice of the person’s profession;
615905 41. 42. “Prescription” means and includes any order for drug or
616906 medical supplies written or signed, or transmitted by word of mouth,
617907 telephone, or other means of co mmunication:
618908 a. by a licensed prescriber,
619-b. under the supervision of an Oklahoma licensed
620-practitioner, an Oklahoma licensed advanced practice
621-registered nurse Advanced Practice Registered Nurse,
622-or an Oklahoma licensed physician assistant, or
623909
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961+practitioner, an Oklahoma licensed advanced practice
962+registered nurse Advanced Practice Registered Nurse,
963+or an Oklahoma licensed physician assistant, or
650964 c. by an Oklahoma licensed wholesaler or distributor as
651965 authorized in Section 353.29.1 of this title;
652966 42. 43. “Product” means a prescription drug in a f inished
653967 dosage form for administration to a patient w ithout substantial
654968 further manufacturing, such as ca psules, tablets, and lyophilized
655969 products before reconstitution. “Product” Product does not include
656970 blood components intended for transfusion, radioactive drugs or
657971 biologics and medical gas;
658972 43. 44. “Repackager”, including “virtual repackager”, means a
659973 person who owns or operates an establishment that repacks and
660974 relabels a product or package for further sale or distribution
661975 without further transaction;
662976 44. 45. “Sterile drug” means a drug that is intended for
663977 parenteral administration, an ophthalmic or oral inhalation drug in
664978 aqueous format, or a drug that is required to be sterile under state
665979 and federal law;
666980 45. 46. “Supervising physician” means an individual holding a
667981 current license to practice as a physician from the State Board of
668982 Medical Licensure and Supervision, pursuant to the provisions of the
669983 Oklahoma Allopathic Medical and Surgical Licensure and Supervision
670-Act, or the State Board of Osteopathic Examiners, pursuant to t he
671-provisions of the Oklahoma Osteopathic Medicine Act, who supervises
672-an advanced practice registered nurse Advanced Practice Registered
673-Nurse as defined in Section 567.3a of this title, and who is not in
674984
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1035+Act, or the State Board of Osteopathic Examiners, pursuant to t he
1036+provisions of the Oklahoma Osteopathic Medicine Act, who supervises
1037+an advanced practice registered nurse Advanced Practice Registered
1038+Nurse as defined in Section 567.3a of this title, and who is not in
7011039 training as an intern, resident, or fellow . To be eligible to
7021040 supervise an advanced practice registered nurse Advanced Practice
7031041 Registered Nurse, such physician shall remain in compliance with the
7041042 rules promulgated by the State Boar d of Medical Licensure and
7051043 Supervision or the State Board of O steopathic Examiners;
7061044 46. 47. “Supportive personnel” means technicians and auxil iary
7071045 supportive persons who are regularly paid employees of a pharmacy
7081046 who work and perform tasks in the pharmacy as authorized by Section
7091047 353.18A of this title;
7101048 47. 48. “Third-party logistics provider” including “virtual
7111049 third-party logistics provider” means an entity that provides or
7121050 coordinates warehousing, or other logistics services of a product in
7131051 interstate commerce on behalf of a manufacturer, wholesale
7141052 distributor, or dispenser of a product but does not t ake ownership
7151053 of the product, nor have res ponsibility to direct the sale or
7161054 disposition of the product. For the purposes of this paragraph,
7171055 “third-party logistics provider” third-party logistics provider does
7181056 not include shippers and the United States Postal Service;
7191057 48. 49. “Wholesale distributor ” including “virtual wholesale
7201058 distributor” means a person other than a manufacturer, a
721-manufacturer’s co-licensed partner, a third-party logistics
722-provider, or repackager engaged in wh olesale distribution as defined
723-by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
724-Act;
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1110+manufacturer’s co-licensed partner, a third-party logistics
1111+provider, or repackager engaged in wh olesale distribution as defined
1112+by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
1113+Act;
7521114 49. 50. “County jail” means a facility operated by a county for
7531115 the physical detention and correction of persons charge d with, or
7541116 convicted of, criminal o ffenses or ordinance violations or persons
7551117 found guilty of civil or criminal contempt;
7561118 50. 51. “State correctional facility” means a facility or
7571119 institution that houses a prisoner population under the jurisdiction
7581120 of the Department of Corrections;
7591121 51. 52. “Unit dose package” means a package that contains a
7601122 single dose drug with the name, strength, control number, and
7611123 expiration date of that drug on the label; and
7621124 52. 53. “Unit of issue package” means a package that provides
7631125 multiple doses of the same drug, but each drug is individually
7641126 separated and includes the name, lot number, and expirat ion date.
7651127 SECTION 3. This act shall become effective July 1, 2024.
7661128 SECTION 4. It being immediately necessary for the prese rvation
7671129 of the public peace, health or safety, an emergenc y is hereby
7681130 declared to exist, by reason whereof this act shall t ake effect and
7691131 be in full force from and after its passage and approval.
770-COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
771-February 15, 2024 - DO PASS
1132+
1133+59-2-3006 DC 1/3/2024 10:39:17 AM